US FDA Verdict Could Ban GSK's Avandia Diabetes Drug
In the latest development in the tortured recent history of its blockbuster diabetes treatment, Avandia, pharmaceuticals firm GlaxoSmithKline will today be delivered an influential opinion on whether it should be banned from the American market. As covered prolifically in previous Pharmaceutical International News Items, Avandia came under fire two months ago, after an article published in the New England Journal of Medicine suggested those prescribed the diabetes drug could be at a greater risk of developing cardiovascular conditions. Now, the advisory committee of the US Food and Drug Administration, in partnership with a number of experts within the medical sphere, will decide whether the risk elements of the treatment are sufficient for it to be withdrawn.
The NEMJ article was published on May 21st 2007. The impact of it was so great that sales figures for Avandia have shed 22 per cent, to rest at £349 million. GSK's share value has simultaneously also been on the descent; a 16 per cent drop in value equating to a loss of approximately £14 billion.
GSK itself has remained adamant that the research is inconclusive, and has defended its star-performing drug all the way. Taking this further, the firm presented the results of tests performed on 400,000 users of Avandia, these not highlighting an increase in the risk of heart problems. For those recorded during the research used in the NEMJ article, GSK favours incidence over fact.
The focus of today's meeting will be to what degree Avandia is capable of incurring cardiovascular complications. The verdict reached at the end of proceedings will not be definitive, given that the FDA will subsequently need to mull over the opinion expressed by the amassed experts. However, similar cases in the past have usually resulted in the FDA complying with the panel.
Reactions within the analytical spectrum have generally sided with the notion that Avandia is unlikely to receive an outright ban. However, it is possible that its sales will be restricted or monitored in some way. Experts at financial firm Citigroup stated, in this regard: "We conclude that the benefits are established, the risks well known (especially that of heart failure) and while there are alternatives they are few in number. The benefit risk ratio has shifted slightly towards risk but not to a degree that would seem to justify withdrawal of Avandia."
Evolution Securities Analyst Peter Cartwright added, to this: "Heavy restrictions on use such as ruling out certain drug combinations or patient groups would impair the product, leaving GSK with a tough commercial call: whether to invest heavily to attempt to rebuild the franchise or whether to accept that the position is irrecoverable and redeploy resources elsewhere."
A commonly-heard verdict is that, whatever the outcome of today's meeting, Avandia's reputation has suffered irrecoverably; precluding any scheme under which it might be relaunched. Commenting last week, analysts from Lehman Brothers said: "Our conversations with doctors at the recent ADA [American Diabetes Association] meeting reveal the Avandia brand to be significantly tarnished and we believe GSK will face significant difficulties in regaining market share."
However, on the positive side, the majority of pharmaceutical industry commentators have highlighted how, even with the possible removal of Avandia from the US drugs market, GSK itself has sufficient product range that it may not suffer significantly.
Pharmaceutical International will cover further developments in Avandia's future as they become known.
Source - Pharmaceutical International's External Contributor
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